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Increased Home-based Physical Therapy Adherence Using BAND Connect's VirtuaCare™ Platform

Primary Purpose

Shoulder Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BAND Connect's VirtuaCare™ platform
Standard of Care Physical Therapy
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Injuries focused on measuring Rotator Cuff Repair, Anatomic and Reverse Total Shoulder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Dr. Brian Grawe will perform surgery, and participants will be undergoing post-operative physical therapy rehabilitation at UC Health. Primary total shoulder arthroplasty and primary reverse total shoulder arthroplasty or Primary rotator cuff repair Outpatient physical therapy prescribed by the doctor for post-operative rehabilitation Exclusion Criteria: Unplanned surgical procedure Partial shoulder replacement or revision shoulder replacement Revision rotator cuff repair Fracture surgeries Prior surgery within the last 5 years or less than 6 months between surgery on opposite shoulder Length of stay in hospital greater than 3 days Comorbidity: Uncontrolled diabetes patients; Diagnosed with cancer in the past 5 years or active disease; Any comorbidity that may impact compliance with the study protocol (completion of standard physical therapy rehabilitation procedures) Injuries related to workers' compensation Injuries involved in any pending litigation

Sites / Locations

  • University of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Group 1 will be using the BAND CVCP both in the clinic and at home to supplement the treatment protocols used in the clinic today.

Group 2 will receive standard-of-care physical therapy without the use of the BAND CVCP.

Outcomes

Primary Outcome Measures

Number of Visits
Number of visits with physical therapist

Secondary Outcome Measures

Full Information

First Posted
May 16, 2023
Last Updated
May 16, 2023
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT05876208
Brief Title
Increased Home-based Physical Therapy Adherence Using BAND Connect's VirtuaCare™ Platform
Official Title
Measuring the Effectiveness of BAND Connect's VirtuaCare™ Asynchronous Telerehabilitation Platform in Increasing Patient Adherence for Total Shoulder Arthroplasty and Rotator Cuff Repair Physical Therapy Rehabilitatio
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to enhance at-home therapy by introducing a new device called the BAND Connect's VirtuaCare™ platform. The study aims to determine whether patients can improve their adherence to at-home exercises using this device. Currently, research indicates that only 35% of patients undergoing physical therapy treatment fully comply with their prescribed plans of care, often neglecting their at-home exercises. To address this issue, a set of smart exercise tools called VirtuaCare™ has been developed. This platform provides patients with instructions on performing at-home exercises and offers real-time biofeedback to help them adjust their form if necessary. The study seeks to evaluate the effectiveness of BAND CVCP in assisting patients and improving their overall success with at-home therapy.
Detailed Description
This study aims to compare the effectiveness of the BAND CVCP device with the standard physical therapy regimens provided by UC Health Orthopaedic Surgery. Participants undergoing shoulder surgeries performed by Dr. Brian Grawe will be randomly assigned to one of two groups. Group 1 will utilize the BAND CVCP both in the clinic and at home as a supplement to their treatment protocols. Group 2 will receive standard physical therapy without the BAND CVCP. In Group 1, participants will be given access to the BAND CVCP and necessary materials during their first physical therapy appointment. The physical therapist will guide them through exercises using the device, recording their actions and providing real-time feedback. The BAND CVCP app on their provided Android phone will offer instructions for each exercise, eliminating the need to memorize the routine. During clinic visits, Group 1 participants' progress will be reviewed using the BAND CVCP participant report. The report will display information such as completed exercises, form, pace, range of motion, and exertion, which is measured by sensors in the BAND CVCP handles. The therapist will help participants understand any corrections needed for their at-home exercises and make adjustments to their rehabilitation plan accordingly. Both Group 1 and Group 2 participants will complete patient report outcomes at different intervals, including pre-operative scores, weekly visual analog scale assessments, and monthly assessments such as the Upper Extremity Functional Index (UEFI) or Quick Disabilities of Arm, Shoulder, and Hand (QuickDASH). Group 1 participants will complete these forms using the BAND CVCP's phone application, while Group 2 participants will use paper copies at the clinic. Additional assessments will be conducted at the 3-month, 6-month, and discharge from care visits, which include the ASES, SST, and EQ-5D-5L forms. Group 1 participants will complete these assessments on the BAND CVCP's phone application, while Group 2 participants will use paper copies at the clinic. This study aims to evaluate the effectiveness of the BAND CVCP device compared to standard physical therapy regimens and track participant rehabilitation outcomes throughout the process.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries
Keywords
Rotator Cuff Repair, Anatomic and Reverse Total Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1 will be using the BAND CVCP both in the clinic and at home to supplement the treatment protocols used in the clinic today.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Group 2 will receive standard-of-care physical therapy without the use of the BAND CVCP.
Intervention Type
Other
Intervention Name(s)
BAND Connect's VirtuaCare™ platform
Intervention Description
Band Connect provides a medical-grade and condition-specific platform that augments the clinician workflow by extending the in-clinic MSK rehabilitation experience into the patient's home - leading to higher quality personalized treatment and increased adherence with enhanced economics and reimbursement for the clinic.
Intervention Type
Other
Intervention Name(s)
Standard of Care Physical Therapy
Intervention Description
Standard of care physical therapy without the use of the BAND CVCP
Primary Outcome Measure Information:
Title
Number of Visits
Description
Number of visits with physical therapist
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dr. Brian Grawe will perform surgery, and participants will be undergoing post-operative physical therapy rehabilitation at UC Health. Primary total shoulder arthroplasty and primary reverse total shoulder arthroplasty or Primary rotator cuff repair Outpatient physical therapy prescribed by the doctor for post-operative rehabilitation Exclusion Criteria: Unplanned surgical procedure Partial shoulder replacement or revision shoulder replacement Revision rotator cuff repair Fracture surgeries Prior surgery within the last 5 years or less than 6 months between surgery on opposite shoulder Length of stay in hospital greater than 3 days Comorbidity: Uncontrolled diabetes patients; Diagnosed with cancer in the past 5 years or active disease; Any comorbidity that may impact compliance with the study protocol (completion of standard physical therapy rehabilitation procedures) Injuries related to workers' compensation Injuries involved in any pending litigation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Hasselfeld
Phone
513-558-1933
Email
hasselky@uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Kloby
Phone
513-558-6077
Email
klobyml@ucmail.uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Grawe, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Hasselfeld
Phone
513-777-6213
Email
hasselky@uc.edu
First Name & Middle Initial & Last Name & Degree
Michael Kloby
Phone
513-558-6077
Email
klobyml@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Brian M Grawe, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Increased Home-based Physical Therapy Adherence Using BAND Connect's VirtuaCare™ Platform

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